OBJECTIVE:To introduce the application of control chart in quality trend analysis and abnormal location manage-ment of pharmaceutical production,thus encourage pharmaceutical manufacturing enterprises to more frequently use control chart as a statistical analysis tool in quality control process. METHODS:Taking a pharmaceutical manufacturing enterprise as examples,the way for selection of different kinds of control charts in different conditions(such as stability study,product quality review)was il-lustrated. Based on the given data of quality characteristic analysis and stability study of a certain product in this company,analysis process was demonstrated using control chart. RESULTS & CONCLUSIONS:When the sample capacity for analysis is not less than 25,meeting the minimum requirement for steady state estimation,Hugh Hart control chart (conventional control chart)alone can accurately locate the abnormal data;while under the adverse circumstance of small sample capacity,the modified control chart (such as the regression control chart)is still able to equally reflect the overall trend and out of trend(OOT)ones. As a statistical analysis tool,control chart introduced into quality management activities is an effective technic way for control.

Objective:To establish a multicriteria value assessment index system, so as to provide reference for hospitals access of medical consumables.Methods:In May 2021, based on the paper previously published, the expert consultation method was used to finalize the index structure, index definitions and scoring standards, along with an importance grading of the indexes. And the index weights were calculated using the analytical hierarchy process. Then the assessment scale was designed by way of multi-criteria decision analysis and mini-HTA. With the linear cutting stapler used as an example, six clinicians, three hospital administrators and the medical consumable management committee made an empirical analysis and evaluation of its general value. The coefficient of variation and Kendall coefficient of concordance were used to test the consistency of clinicians′ scores.Results:Three rounds of expert consultations finalized an index structure with 4 level-1 and 11 level-2 indexes, and on such basis a multicriteria value assessment index system for hospital access of medical consumables was established. This system comprised the clinician evaluation scale, hospital administrator evaluation scale and medical consumable management committee evaluation scale. The first two of which were used for preliminary screening, and the third for a full-scale, detailed and quantitative evaluation of those selected, hence a decision was made in the end according to the weighted sum of the three scales. This scale system was used to evaluate a foreign brand and a domestic brand of linear cutting staplers, while the former and the latter scored 90.5 and 75.4 respectively. Statistical analysis of the six clinicians found a coefficient of variation CV<0.25, and the Kendall coefficient of concordance W=0.833, proving good consistency of the evaluation criteria and results. Conclusions:The multicriteria value assessment index system proves highly scientific, comprehensive and practicable, serving a good reference for hospitals to build their value-based mechanism to select medical consumables.

OBJECTIVETo study subtype classification of gastric neuroendocrine neoplasm (NEN) and their clinicopathological characteristics in order to provide reference for clinical practice.

METHODSClinicopathological data of 241 gastric NEN patients (174 cases from China-Japan Friendship Hospital and 67 cases from The First Affiliated Hospital of Sun Yat-Sen University) between January 2011 and June 2016 were retrospectively summarized. According to serum gastrin, 24-hour intragastric pH monitoring and pathological grade, patients with gastric NEN were divided into 4 types: type I( (hypergastrinemia and achlorhydria, related to autoimmune chronic atrophic gastritis), type II( [hypergastrinemia and Zollinger-Ellison syndrome, related to gastrinoma or multiple endocrine neoplasia type I( (MEN-I()], type III( (sporadic disease with normal serum gastrin level), and type IIII( [poorly differentiated gastric neuroendocrine carcinoma (NEC) and mixed adenoneuroendocrine carcinoma (MANEC)]. Clinicopathological features, treatment and prognosis of 4 types were analyzed.

RESULTSOf 241 gastric NEN cases, there were 86 cases (35.7%) in type I(, 7 cases (2.9%) in type II(, 61 cases (25.3%) in type III( and 87 cases(36.1%) in type IIII(. Among 86 cases of type I( gastric NEN, 73 cases (84.9%) were multiple lesions,tumor size of 66 cases (76.7%) was less than 1 cm, all the 86 cases were polypoid or granular lesions. 2 cases(2.3%)presented distant metastasis, 69 cases (80.2%) had pathological grading as NET G1; most of them received endoscopic surgery treatment and follow-up; somatostatin analogs(SSA) was used in patients with multiple lesions and repeated recurrence after endoscopic treatment. Among 7 cases of type II(, 4 cases were gastrinoma, 3 cases MEN-I(; 5 cases presented distant metastasis; treatment included surgery, SSA and proton pump inhibitor (PPI) therapy. Among 61 cases of type III( gastric NEN, 49 cases(80.3%) were single lesion,tumor size of 25 cases(41.0%) was more than 2 cm, 29 cases(47.5%) had lymph node metastasis or distant metastasis; treatment included endoscopic resection, surgery or SSA therapy according to the tumor staging. Among 87 patients of type IIII( gastric NEN, 74 cases(85.0%) had single lesion,tumor size of 51 cases (58.6%) was more than 2 cm; lesions were found in gastric cardia in 35 cases (40.2%); 65 cases (74.7%) had lymph node metastasis or distant metastasis; treatment included chemotherapy, or surgery plus chemotherapy. At the end of follow-up(June 30, 2016), 58 patients were dead, including 1 case of type I(, 12 cases of type III( and 45 cases of type IIII(. The overall survival rate of all the patients was 74.2%, and was 98.8%, 100%, 79.3%, 39.2% of types I(, II(, III(, IIII( respectively. The overall survival rate between type III( and type IIII( gastric NEN was significantly different(P = 0.000).

CONCLUSIONSSubtype classification of gastric NEN is very significant for making therapeutic decisions and prognostic evaluation. Patients of type I( or type II( gastric NEN have good prognosis,while those of type III( and type IIII( have poor prognosis, and those of type IIII( have the worst prognosis.

Adult ; China ; Female ; Humans ; Lymphatic Metastasis ; Male ; Neoplasm Recurrence, Local ; Neoplasm Staging ; Neuroendocrine Tumors ; pathology ; therapy ; Prognosis ; Retrospective Studies ; Stomach Neoplasms ; pathology ; therapy ; Survival Rate